Monitoring small kidney tumors without immediate surgery
European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study)
Azienda Ospedaliero Universitaria Maggiore della Carita · NCT06336187
This study is testing whether people with small kidney tumors can safely skip surgery and be monitored instead, to see how well they do over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita (other) |
| Locations | 1 site (Novara) |
| Trial ID | NCT06336187 on ClinicalTrials.gov |
What this trial studies
This observational, multi-national study aims to evaluate the overall survival of patients diagnosed with small renal cell carcinoma (RCC) measuring less than 4 cm, who are managed through active surveillance instead of invasive treatments. Participants will undergo a percutaneous biopsy to confirm the diagnosis of RCC and will be monitored for tumor growth and progression over time. The study seeks to establish a standardized follow-up protocol and identify genetic markers that may indicate tumor aggressiveness, aiding in personalized management strategies for patients. A total of 400 patients across European countries will be included in this prospective study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with incidentally diagnosed, histologically confirmed small renal masses who are unfit for active treatment due to age or comorbidities.
Not a fit: Patients with larger tumors, metastatic disease, or those with non-RCC histology will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow patients with small RCC to avoid unnecessary surgeries while still effectively managing their condition.
How similar studies have performed: Previous studies on active surveillance for small renal tumors have shown promise, but this study focuses specifically on histologically confirmed RCC, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males or females, age ≥ 18 years * Incidental diagnosis at imaging (ultrasonography, CT, MRI) of a solid renal mass \< 4 cm in maximum diameter. * Histologically confirmed RCC by percutaneous needle biopsy at diagnosis. All RCC subtypes are eligible for the study. * Patients unfit for active treatment due to advanced age, or co-morbidity, or choosing to avoid active treatment. * Signed Informed consent. * Preparedness to comply with percutaneous tumor biopsy and a close follow-up protocol Exclusion Criteria: * Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.). * Presence of metastatic disease at diagnosis * Tumor related symptoms at presentation. * Patients with known genetic diseases associated with RCC (Von Hippel-Lindau, Birt-Hogg-Dubé, Hereditary Leiomyomatosis and Renal Cell Cancer, etc.). * Patients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued. * Patients unsuitable for biopsy due to tumor location or small tumor size. * Patients with concurrent systemic treatment for another cancer. * Patients with estimated life expectancy \< 1 year.
Where this trial is running
Novara
- Ospedale Maggiore della Carità — Novara, Italy (RECRUITING)
Study contacts
- Study coordinator: Alessandro Volpe, MD
- Email: alessandro.volpe@med.uniupo.it
- Phone: 0321373201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Cell Carcinoma, active surveillance, small renal masses